Health-related quality of life in advanced gastric/gastroesophageal junction cancer with second-line pembrolizumab in KEYNOTE-061

Eric Van Cutsem, Mayur Amonkar, Charles S. Fuchs, Maria Alsina, Mustafa Özgüroğlu, Yung Jue Bang, Hyun Cheol Chung, Kei Muro, Eray Goekkurt, Al B. Benson, Weijing Sun, Zev A. Wainberg, Josephine M. Norquist, Xinqun Chen, Chie Schin Shih, Kohei Shitara

Research output: Contribution to journalArticlepeer-review

3 Citations (Scopus)


Background: In the primary analysis population (i.e., PD-L1 combined positive score [CPS] ≥ 1) of the phase 3 KEYNOTE-061 study (NCT02370498), pembrolizumab did not significantly prolong overall survival or progression-free survival. Pembrolizumab had a favorable safety profile in the all-patient population. We present results of prespecified health-related quality of life (HRQoL) analyses. Methods: HRQoL was measured using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), EORTC QLQ gastric cancer questionnaire (QLQ-STO22), and EuroQol 5-dimension, 3-level questionnaire (EQ-5D-3L). Data were analyzed from patients who received ≥ 1 dose of study treatment and who completed ≥ 1 HRQoL assessment. Key analyses included baseline to week 12 least-squares mean (LSM) change in global health status (GHS)/QoL, functional/symptom subscales, and time to deterioration (TTD; ≥ 10-point decrease from baseline) for specific subscales. Results: The HRQoL population included 371 patients (pembrolizumab, n = 188; paclitaxel, n = 183). Compliance and completion rates for all 3 questionnaires were similar in both groups at baseline and week 12. There was no difference in LSM change between groups (– 3.54; 95% CI – 8.92 to 1.84) in GHS/QoL at week 12. LSM change from baseline to week 12 for most QLQ-C30, QLQ-STO22, and EQ-5D-3L subscales indicated some worsening of QoL in both groups. TTD for GHS/QoL, nausea/vomiting, and appetite loss subscales in QLQ-C30 and the pain subscales in QLQ-STO22 were similar between treatment groups. Conclusions: In this population with advanced gastric and GEJ cancer receiving second-line treatment, HRQoL was similar in patients receiving pembrolizumab and those receiving paclitaxel. Clinical trial registry and number:, NCT02370498.

Original languageEnglish
Pages (from-to)1330-1340
Number of pages11
JournalGastric Cancer
Issue number6
Publication statusPublished - 2021 Nov

Bibliographical note

Funding Information:
We thank the patients and their families as well as the investigators and site personnel involved in the study. Medical writing and/or editorial assistance was provided by Tim Peoples, MA, ELS, Traci Stuve, MA, and Holly C. Cappelli, PhD, CMPP, of ApotheCom (Yardley, PA, USA). This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Publisher Copyright:
© 2021, The Author(s).

All Science Journal Classification (ASJC) codes

  • Oncology
  • Gastroenterology
  • Cancer Research


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